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NCT04248322 Clinical Trial

Qualitative Assessment of the Impact of TTNS on QOL and Participation

Spinal Cord Injuries Clinical Trial

Official title:
Qualitative Assessment of the Impact of Transcutaneous Tibial Nerve Stimulation (TTNS) on Quality of Life and Participation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04248322
Other study ID # STUDY00004862
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 31, 2022
Est. completion date October 2024

Study information
Verified date September 2023
Source Medstar Health Research Institute
Contact Amanda K Rounds, PhD
Phone 2028771591
Email Amanda.K.Rounds@medstar.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study through the use of semi-structured interviews or focus groups will explore the lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

Description:

Identify NLUTD user-defined themes regarding bladder function and and the daily impacts on one's life Specific Aim: Using iterative, semi-structured interviews or focus groups to explore the lived experience using TTNS neuromodulation to generate user-defined themes regarding bladder function and the daily impacts on one's life.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion: Participated in TTNS Study for 1 year.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Semi-structured interview
Using iterative, semi-structured interviews or focus groups to explore the lived experience with CC and usual customary care (UCC) of catheter users with NLUTD and their caretakers to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

Locations
Country Name City State
United States MedStar National Rehabilitation Hospital Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Consumer user-defined themes from qualitative interviews Explore the lived experience using the transcutaneous tibial nerve stimulation to generate user-defined themes regarding bladder function and the daily impacts on one's life. Qualitative analysis will be used to define these themes about how TTNS impacted ones life, and bladder function Collected once at study completion at 1 year
Secondary Follow-up calls regarding user-defined themes Possible follow-up calls for clarification on user-defined themes (primary outcome) may need to be done to through study completion, an average of 1 year
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